FDA Adverse Event
Malfunction
Summary report: N
RSVR MMT-332A 10PK PRDGM 3CC 14L
MDR report key: 1942234
·
Received December 22, 2010
Report
- Report Number
- 2032227-2010-83531
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 8, 2010
- Report Date
- December 9, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT INSULIN LEAKED FROM THE RESERVOIR. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSVR MMT-332A 10PK PRDGM 3CC 14L | RESERVOIR | FRN | MEDTRONIC MINIMED | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |